NAFLDNCT03365531
RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease
A study testing Alternate Daily Fasting (ADF) and Caloric Restriction (CR) in people with NAFLD and Obesity, run by University of Florida at 1 site in United States.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD, Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Alternate Daily Fasting (ADF) and Caloric Restriction (CR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
- Patient must be at least 18 years at the time of consent Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration. Refer to Appendix IV for clarification on study eligibility and AJCC stage group.
- Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
- A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
- A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.
- Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater.
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- Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
- Zubrod performance status must be 0-1 within 4 months prior to registration.
- If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy. Please document as such.
- Patients must be able to start treatment within 16 weeks of registration.
Who cannot join
- T4 prostate disease on CT, MRI, or physical exam.
- Patients unable to undergo MRI of the prostate.
- Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
- IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
- Evidence of distant metastasis (M1).
- Patients with positive nodes on cross-sectional imaging.
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- Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy.
- Prior pelvic radiation therapy.
- No prior myocardial infarction within the last 6 months, congestive heart failure, or end stage renal disease.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum.
- Bilateral hip replacement
- Prior intrapelvic surgery. This includes the following:Bladder surgery,Transrectal or rectal surgery other than prostate biopsy, Polypectomy or hemorrhoid removal or banding
- Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH).
- Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).
- Patients with posterior or posterolateral extracapsular extension of prostate cancer. If this is present, it must resolve on diagnostic MRI after 2 to 3 months of neoadjuvant androgen deprivation therapy prior to enrollment. Refer to Appendix V for definition of extracapsular extension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Caloric Restriction vs. Alternate-Day Fasting in Patients With Non-Alcoholic Fatty Liver Disease
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF) is safe and well tolerated in obese patients and there might be additional beneficial effects. The objective is to combine the expertise of the PI with this novel intervention and the expertise of Dr. Cusi in NAFLD to explore the effects of ADF vs CR in patients with NAFLD and T2DM to test the following hypotheses:
H1: In patients with NAFLD and T2DM, the ADF intervention will result in more favorable metabolic changes than CR:
H1a: Hepatic triglyceride by MRS will decrease more with ADF than CR (Primary Outcome) and remain lower following a period of free living H1b: There will be greater improvements in glucose homeostasis following ADF vs CR H1c: There will be greater improvement in lipid metabolism following ADF vs CR and changes in ketone metabolism will predict changes in hepatic triglyceride content H2: ADF will have similar safety and tolerability and result in a similar degree of weight loss in participants with NAFLD and DM compared to CR
Read the detailed description
Rationale:
Non alcoholic fatty liver disease (NAFLD) has a prevalence of up to 80% in patients with T2DM and obesity and can lead to steatohepatitis (NASH) and fibrosis as well as cirrhosis and hepatocellular carcinoma. As NAFLD is associated with increased risk of cardiovascular disease and mortality and as NAFLD-induced liver disease is anticipated to be the most common indication for liver transplantation over the next decade, treatment options are desperately needed but very few are available.
Weight loss with caloric restriction (CR) is the preferred treatment of NAFLD, however successful maintenance of a significant weight loss is difficult to achieve. Additionally, despite significant association between degree of weight loss and improvements in NASH and NAFLD, there is extensive overlap in the response among populations. This suggests that it may not be weight loss in general, but rather the mechanistic underpinnings of the weight loss that potentiate the therapeutic effects. A study comparing dietary carbohydrate restriction vs CR in obese subjects with NAFLD found that, despite similar weight loss between groups, there was greater hepatic triglyceride reduction with carbohydrate restriction and this reduction was highly correlated with plasma ketone concentrations. Hence, although weight loss is ostensibly important, there might be additional factors beyond just weight loss per se causing the improvements in NASH. Therefore, rather than weight loss, reduction in intrahepatic triglyceride will be the primary endpoint of this proposal.
Progression to NASH and beyond is largely due to a spectrum of metabolic abnormalities including ectopic hepatic fat accumulation, insulin resistance, and abnormal lipid metabolism. A recent animal study showed blunted ketogenesis in NASH and suggested the overall etiology was due to inefficient oxidation and disposal of free fatty acids in the liver. A fasting paradigm, or facilitating times of ketosis that could then normalize lipid metabolism, might be one of the additional factors beyond weight loss that ensures improvements in NAFLD and NASH.
Intermittent fasting (IF) is a dietary intervention whereby food is restricted for varying timeframes, including alternate day fasting (ADF) where no or very few calories are given for a day or more with ad lib feeding in between. In animal models, IF has been shown to have numerous beneficial effects, many in excess of those seen with CR. In a mouse model of NAFLD, IF resulted in improvements in hepatic steatosis and inflammation along with gene expression changes showing enhanced activation of lipid oxidation and reduction of lipid synthesis. These benefits may be due to "flipping the metabolic switch" from glucose to ketone utilization for primary cellular energy needs. Data are only beginning to emerge on the effects of IF in humans, and very few studies have focused on ketone production as a mediator of positive outcomes. There are no data on the effect of ADF on NAFLD.
Specific Aims:
SA1: To compare the effect of ADF vs CR on metabolic changes including liver fat, glucose homeostasis, lipid metabolism, and inflammation in patients with NAFLD and T2DM SA1a: To determine changes in hepatic triglyceride by MRS after 4 weeks of ADF and after 4 weeks of ad lib diet SA1b: To determine changes in glucose homeostasis SA1c: To determine changes in whole body lipid metabolism and inflammation SA2: To determine the safety, tolerability, and effectiveness on weight loss of ADF vs CR SA2a: To determine safety of ADF SA2b: To compare changes in body weight, body composition, physical activity, physical functioning and physical fitness SA2c: To determine effect on eating behaviors, hunger/satiety, and body image SA2d: To determine effect on cognition and quality of life
- Conditions
- NAFLD, Obesity, Diabetes Mellitus, Type 2
- Being tested
- Alternate Daily Fasting (ADF), Caloric Restriction (CR)
- Keywords
- fasting
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Diabetes Mellitus, Type 2, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Daily Fasting (ADF)Other
See ADF arm for details
Caloric Restriction (CR)Other
See CR arm for details
| Study group | Role | What they receive |
|---|---|---|
| Alternate Daily Fasting (ADF) | Experimental | Participants randomized to the ADF group will alternate between a day of ad lib feeding and a day of nearly no energy intake. Participants will be prescribed a core diet for feeding days that meets 110% of their estimated calorie needs within the fixed macronutrient distribution of 50% CHO, 20% PRO, and 30% FAT. In accordance with the ad lib feeding protocol, optional modules of similar macronutrient content will be prescribed, each providing an additional 200 kcals. Meal timing will not be restricted on these days. On fasting days, participants will be asked to consume 16 oz. of G2 Gatorade (40 kcal) in the morning and then only water or non-caloric beverages for the rest of the day. Receives: Other: Alternate Daily Fasting (ADF) |
| Caloric Restriction | Active comparator | Participants randomized to the CR group will consume a diet of fixed energy designed to yield a 500 kcal/d deficit with a macronutrient distribution of 50% CHO, 20% PRO, and 30% FAT. Meal timing and caloric distribution will not be restricted. Receives: Other: Caloric Restriction (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Triglyceride by MRS
To determine changes in hepatic triglyceride by MRS after 4 weeks of ADF (Primary outcome) and after 4 weeks of ad lib diet
Measured: Baseline up to 8 weeks
Secondary outcomes (9)
Changes in Glucose Homeostasis
To determine changes in glucose homeostasis as measured by: Overall and hepatic insulin sensitivity following OGTT using the Matusda index
Measured: Baseline through 4 weeks
Changes in whole body lipid metabolism - Adipose tissue insulin sensitivity by AdipoIR and fasting and postprandial free fatty acid excursion
To determine changes in whole body lipid metabolism and inflammation as measured by: Adipose tissue insulin sensitivity by AdipoIR and fasting and postprandial free fatty acid excursion. Adipo-IR index (fasting, FFAs x insulin.
Measured: Baseline through 4 weeks
Safety of ADF -Liver Magnetic Resonance Spectroscopy (MRS)
MRS to determine hepatic fat content and elasticity
Measured: Baseline through 4 weeks
Safety of ADF -Fibroscan.
For liver steatosis (CAP) and fibrosis (VCTE) measurements
Measured: Baseline through 4 weeks
Safety of ADF - blood
To determine safety of ADF measured by complete metabolic panel, glucose, ketones, and free fatty acids
Measured: Baseline through 4 weeks
To compare changes body composition measured
To compare changes in body weight, body composition measured by: Dual-energy x-ray absorptiometry (DEXA) to include weight
Measured: Baseline up to 8 weeks
Effect on eating behaviors
Binge Eating Disorder Questionnaire: individuals can be categorized into three groups according to established cut-scores of binge eating severity. These groups are characterized by no binge eating (score ≤ 17), mild to moderate binge eating (score of 18 - 26) and severe binge eating (score ≥ 27)
Measured: Baseline up to 8 weeks
Cognitive function
Effect on cognition and quality of life NIH Cognitive Toolbox
Measured: Baseline up to 8 weeks
Diet Tolerability
ADF NAFLD Diet Tolerability a Likert scale design from 1-5, with 5 as strongly agree evaluating feasting days.
Measured: Baseline up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Mar 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: Inadequate enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial of Caloric Restriction vs. Alternate-Day Fasting
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William T Donahoo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365531
- Sponsor's protocol ID
- IRB201701956
- Other IDs
- OCR16250
- Status last verified
- Sep 2019
- First submitted
- 20 Oct 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to determine if able to de-identify enough relevant individual participant data to make sharing worthwhile and appropriate for this very small study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Caloric Restriction vs. Alternate-Day Fasting in Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03365531
- Acronym / sponsor ID
- IRB201701956
- Conditions
- NAFLD, Obesity, Diabetes Mellitus, Type 2
- Keywords
- fasting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF) is safe and well tolerated in obese patients and there might be additional beneficial effects. The objective is to combine the expertise of the PI with this novel intervention and the expertise of Dr. Cusi in NAFLD to explore the effects of ADF vs CR in patients with NAFLD and T2DM to test the following hypotheses:
H1: In patients with NAFLD and T2DM, the ADF intervention will result in more favorable metabolic changes than CR:
H1a: Hepatic triglyceride by MRS will decrease more with ADF than CR (Primary Outcome) and remain lower following a period of free living H1b: There will be greater improvements in glucose homeostasis following ADF vs CR H1c: There will be greater improvement in lipid metabolism following ADF vs CR and changes in ketone metabolism will predict changes in hepatic triglyceride content H2: ADF will have similar safety and tolerability and result in a similar degree of weight loss in participants with NAFLD and DM compared to CR
Detailed description
Rationale:
Non alcoholic fatty liver disease (NAFLD) has a prevalence of up to 80% in patients with T2DM and obesity and can lead to steatohepatitis (NASH) and fibrosis as well as cirrhosis and hepatocellular carcinoma. As NAFLD is associated with increased risk of cardiovascular disease and mortality and as NAFLD-induced liver disease is anticipated to be the most common indication for liver transplantation over the next decade, treatment options are desperately needed but very few are available.
Weight loss with caloric restriction (CR) is the preferred treatment of NAFLD, however successful maintenance of a significant weight loss is difficult to achieve. Additionally, despite significant association between degree of weight loss and improvements in NASH and NAFLD, there is extensive overlap in the response among populations. This suggests that it may not be weight loss in general, but rather the mechanistic underpinnings of the weight loss that potentiate the therapeutic effects. A study comparing dietary carbohydrate restriction vs CR in obese subjects with NAFLD found that, despite similar weight loss between groups, there was greater hepatic triglyceride reduction with carbohydrate restriction and this reduction was highly correlated with plasma ketone concentrations. Hence, although weight loss is ostensibly important, there might be additional factors beyond just weight loss per se causing the improvements in NASH. Therefore, rather than weight loss, reduction in intrahepatic triglyceride will be the primary endpoint of this proposal.
Progression to NASH and beyond is largely due to a spectrum of metabolic abnormalities including ectopic hepatic fat accumulation, insulin resistance, and abnormal lipid metabolism. A recent animal study showed blunted ketogenesis in NASH and suggested the overall etiology was due to inefficient oxidation and disposal of free fatty acids in the liver. A fasting paradigm, or facilitating times of ketosis that could then normalize lipid metabolism, might be one of the additional factors beyond weight loss that ensures improvements in NAFLD and NASH.
Intermittent fasting (IF) is a dietary intervention whereby food is restricted for varying timeframes, including alternate day fasting (ADF) where no or very few calories are given for a day or more with ad lib feeding in between. In animal models, IF has been shown to have numerous beneficial effects, many in excess of those seen with CR. In a mouse model of NAFLD, IF resulted in improvements in hepatic steatosis and inflammation along with gene expression changes showing enhanced activation of lipid oxidation and reduction of lipid synthesis. These benefits may be due to "flipping the metabolic switch" from glucose to ketone utilization for primary cellular energy needs. Data are only beginning to emerge on the effects of IF in humans, and very few studies have focused on ketone production as a mediator of positive outcomes. There are no data on the effect of ADF on NAFLD.
Specific Aims:
SA1: To compare the effect of ADF vs CR on metabolic changes including liver fat, glucose homeostasis, lipid metabolism, and inflammation in patients with NAFLD and T2DM SA1a: To determine changes in hepatic triglyceride by MRS after 4 weeks of ADF and after 4 weeks of ad lib diet SA1b: To determine changes in glucose homeostasis SA1c: To determine changes in whole body lipid metabolism and inflammation SA2: To determine the safety, tolerability, and effectiveness on weight loss of ADF vs CR SA2a: To determine safety of ADF SA2b: To compare changes in body weight, body composition, physical activity, physical functioning and physical fitness SA2c: To determine effect on eating behaviors, hunger/satiety, and body image SA2d: To determine effect on cognition and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial of Caloric Restriction vs. Alternate-Day Fasting
| Arm | Type | Receives |
|---|---|---|
| Alternate Daily Fasting (ADF) | Experimental | Other: Alternate Daily Fasting (ADF)Participants randomized to the ADF group will alternate between a day of ad lib feeding and a day of nearly no energy intake. Participants will be prescribed a core diet for feeding days that meets 110% of their estimated calorie needs within the fixed macronutrient distribution of 50% CHO, 20% PRO, and 30% FAT. In accordance with the ad lib feeding protocol, optional modules of similar macronutrient content will be prescribed, each providing an additional 200 kcals. Meal timing will not be restricted on these days. On fasting days, participants will be asked to consume 16 oz. of G2 Gatorade (40 kcal) in the morning and then only water or non-caloric beverages for the rest of the day. |
| Caloric Restriction | Active comparator | Other: Caloric Restriction (CR)Participants randomized to the CR group will consume a diet of fixed energy designed to yield a 500 kcal/d deficit with a macronutrient distribution of 50% CHO, 20% PRO, and 30% FAT. Meal timing and caloric distribution will not be restricted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
- Patient must be at least 18 years at the time of consent Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration. Refer to Appendix IV for clarification on study eligibility and AJCC stage group.
- Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
- A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
- A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.
Key exclusion criteria (15 listed)
- T4 prostate disease on CT, MRI, or physical exam.
- Patients unable to undergo MRI of the prostate.
- Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
- IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
- Evidence of distant metastasis (M1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Daily Fasting (ADF)See ADF arm for details | Other | Alternate Daily Fasting (ADF) |
| Caloric Restriction (CR)See CR arm for details | Other | Caloric Restriction |
Primary outcome
Hepatic Triglyceride by MRS
Time frame: Baseline up to 8 weeks
To determine changes in hepatic triglyceride by MRS after 4 weeks of ADF (Primary outcome) and after 4 weeks of ad lib diet
9 secondary outcomes
Changes in Glucose Homeostasis
Time frame: Baseline through 4 weeks
Changes in whole body lipid metabolism - Adipose tissue insulin sensitivity by AdipoIR and fasting and postprandial free fatty acid excursion
Time frame: Baseline through 4 weeks
Safety of ADF -Liver Magnetic Resonance Spectroscopy (MRS)
Time frame: Baseline through 4 weeks
Safety of ADF -Fibroscan.
Time frame: Baseline through 4 weeks
Safety of ADF - blood
Time frame: Baseline through 4 weeks
To compare changes body composition measured
Time frame: Baseline up to 8 weeks
Effect on eating behaviors
Time frame: Baseline up to 8 weeks
Cognitive function
Time frame: Baseline up to 8 weeks
Diet Tolerability
Time frame: Baseline up to 8 weeks
Results and safety
The study was stopped early (reason given: Inadequate enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Undecided. Need to determine if able to de-identify enough relevant individual participant data to make sharing worthwhile and appropriate for this very small study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Donahoo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Daily Fasting (ADF) and Caloric Restriction (CR) in people with NAFLD and Obesity, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Triglyceride by MRS (time frame: Baseline up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.